FDA Recalls Compounded Intrathecal Solution Due to Sterility Concerns
The Compounding Pharmacy of America is recalling a compounded intrathecal solution because an FDA inspection found GMP violations that may affect sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II and involves a sterile intrathecal product where sterility assurance is compromised, posing a significant risk of serious injury or death from infection.
Plain-English summary
The Compounding Pharmacy of America is recalling Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free. The product is a 22 ml sterile solution intended for intrathecal use.
The recall was initiated because an FDA inspection identified Good Manufacturing Practice (GMP) violations that potentially impact the product's quality and sterility. The agency has classified this as a Class II recall.
The affected lots were distributed nationwide between November 2014 and May 2015. Specific lot codes include 03242015@81 and 6/22/2015. Patients and healthcare providers should stop using the product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Hydromorphone 35 mg/ml + Bupivacaine 10 mg/ml + Baclofen 1,500 mcg/ml + Clonidine 200 mcg/ml Intrathecal Solution, Sterile-Preservative Free, The Compounding Pharmacy of America, Knoxville, TN
- Manufacturer
- The Compounding Pharmacy of America
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- All lots distributed between November 2014 and May 2015
- 03242015@81
- 6/22/2015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 382 recalled by The Compounding Pharmacy of America under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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